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This study aims to compare the efficacy of a one-time IM dose of dexamethasone versus a 5-day course of prednisone in adult ED patients presenting with asthma exacerbations. This is a randomized, controlled, double-blind, non-inferiority trial conducted at two urban EDs within the Montefiore Health System.
Asthma exacerbations are a leading cause of emergency department (ED) visits in the United States. In pediatric patients, a single dose of dexamethasone has been widely adopted as an effective and convenient alternative to multi-day oral steroid regimens. However, in adults, evidence regarding the efficacy of a single-dose steroid approach compared to a traditional 5-day course of oral prednisone is mixed. Despite the availability of oral corticosteroids like prednisone, medication adherence after ED discharge remains a significant challenge. Studies indicate that only about 30% of ED patients fill prescribed medications post-discharge. A single-dose intramuscular (IM) dexamethasone regimen offers the advantage of ensuring adequate anti-inflammatory effects for asthma exacerbations. This study aims to compare the efficacy of a one-time IM dose of dexamethasone versus a 5-day course of prednisone in adult ED patients presenting with asthma exacerbations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Intramuscular Steroid Injection | Active Comparator | Dexamethasone 16mg Intramuscular Single Dose |
|
| Oral Steroid Short Course | Active Comparator | Prednisone 60mg PO for 5 Days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone 16mg IM | Drug | Dexamethasone 16mg Intramuscular Administration Once |
|
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Control Test Score | Asthma control will be assessed via administration of the Asthma Control Test (ACT) questionnaire at 4 weeks post-discharge. The ACT questionnaire is comprised of 5 questions which ask participants to recall how asthma symptoms have affected them over the prior 4 weeks. Responses to the 5 questions are rated on a 5-point Likert scale ranging from 1-5, yielding an overall possible scoring range of 5-25. Higher ACT scores are indicative of better asthma control. For this study, an ACT score >19 indicates well-controlled asthma. Scores will be summarized by study arm using basic descriptive statistics. | Within 4 Weeks post-discharge, up to 28-30 days |
| Measure | Description | Time Frame |
|---|---|---|
| ED or Hospitalization for Asthma | The number of return visits to the ED or hospitalizations related to asthma, within 30 days post-discharge, will be summarized by study arm using basic descriptive statistics. | Within 4 Weeks post-discharge, up to 28-30 days |
| Change in Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mustfa Manzur, MD MPH MS | Contact | 718-920-6626 | mmanzur@montefiore.org |
| Name | Affiliation | Role |
|---|---|---|
| Carlo Lutz, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33387672 | Background | Hasegawa K, Craig SS, Teach SJ, Camargo CA Jr. Management of Asthma Exacerbations in the Emergency Department. J Allergy Clin Immunol Pract. 2021 Jul;9(7):2599-2610. doi: 10.1016/j.jaip.2020.12.037. Epub 2020 Dec 31. | |
| 24515516 | Background | Keeney GE, Gray MP, Morrison AK, Levas MN, Kessler EA, Hill GD, Gorelick MH, Jackson JL. Dexamethasone for acute asthma exacerbations in children: a meta-analysis. Pediatrics. 2014 Mar;133(3):493-9. doi: 10.1542/peds.2013-2273. Epub 2014 Feb 10. |
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Individual participant data will not be shared.
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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Participants will be randomly assigned 1:1 to a treatment group using a computer-generated randomization schedule.
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Participants, treating physicians, nursing, and the investigators will remain blinded to treatment allocation. Blinded medications will be pre-packaged by the clinical research pharmacy team.
| Prednisone 60mg PO | Drug | Prednisone 60mg PO for 5 Days |
|
Change in Quality of Life will be measured using the Mini Asthma Quality of Life Questionnaire (MiniAQLQ). The MiniAQLQ is a 21-item survey which consists of questions spanning four domains: symptoms, activity limitations, emotional function, and environmental stimuli, in order to understand how asthma affects patients in daily life. Responses to the first 15 questions are rated on a 7-point scale ranging from 1-7, questions 16-20 are rated using a 3-point scale ranging from 1-3, and question 21 is rated on 0-10 scale, with higher scores being indicative of a better quality of life, yielding an overall possible scoring range of 20-130. Scores will be summarized by study arm. |
| At 2 weeks (at approximately 14-15 days) and 4 weeks post-discharge relative to baseline, up to 28-30 days |
| Adverse Effects | Documented occurrence of Adverse Effects, including nausea, headache, rash, or Serious Adverse Events, as defined by International Conference on Harmonisation - Good Clinical Practice (ICH GCP) guidelines, will be summarized by study arm. | At Day 0 and 4-weeks post-discharge relative to baseline, up to 28-30 days |
| 29859017 | Background | Kirkland SW, Cross E, Campbell S, Villa-Roel C, Rowe BH. Intramuscular versus oral corticosteroids to reduce relapses following discharge from the emergency department for acute asthma. Cochrane Database Syst Rev. 2018 Jun 2;6(6):CD012629. doi: 10.1002/14651858.CD012629.pub2. |
| 25615001 | Background | Fischer MA, Jones JB, Wright E, Van Loan RP, Xie J, Gallagher L, Wurst AM, Shrank WH. A randomized telephone intervention trial to reduce primary medication nonadherence. J Manag Care Spec Pharm. 2015 Feb;21(2):124-31. doi: 10.18553/jmcp.2015.21.2.124. |
| 17726409 | Background | Gordon S, Tompkins T, Dayan PS. Randomized trial of single-dose intramuscular dexamethasone compared with prednisolone for children with acute asthma. Pediatr Emerg Care. 2007 Aug;23(8):521-7. doi: 10.1097/PEC.0b013e318128f821. |
| 11445789 | Background | Qureshi F, Zaritsky A, Poirier MP. Comparative efficacy of oral dexamethasone versus oral prednisone in acute pediatric asthma. J Pediatr. 2001 Jul;139(1):20-6. doi: 10.1067/mpd.2001.115021. |
| 33377411 | Background | Nelsen LM, Kosinski M, Rizio AA, Jacques L, Schatz M, Stanford RH, Svedsater H. A structured review evaluating content validity of the Asthma Control Test, and its consistency with U.S. guidelines and patient expectations for asthma control. J Asthma. 2022 Mar;59(3):628-637. doi: 10.1080/02770903.2020.1861624. Epub 2020 Dec 30. |
| 10489826 | Background | Juniper EF, Guyatt GH, Cox FM, Ferrie PJ, King DR. Development and validation of the Mini Asthma Quality of Life Questionnaire. Eur Respir J. 1999 Jul;14(1):32-8. doi: 10.1034/j.1399-3003.1999.14a08.x. |
| 26556901 | Background | Alzahrani YA, Becker EA. Asthma Control Assessment Tools. Respir Care. 2016 Jan;61(1):106-16. doi: 10.4187/respcare.04341. Epub 2015 Nov 10. |
| 19767070 | Background | Schatz M, Kosinski M, Yarlas AS, Hanlon J, Watson ME, Jhingran P. The minimally important difference of the Asthma Control Test. J Allergy Clin Immunol. 2009 Oct;124(4):719-23.e1. doi: 10.1016/j.jaci.2009.06.053. Epub 2009 Sep 19. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D011244 | Pregnadienediols |